(86 days)
Yes
The device description explicitly states that it "gathers and analyzes information" to "generate recommendations for adjustments to the patient's insulin therapy parameters." While the terms AI or ML are not explicitly used, the function of analyzing complex patient data (glucose readings, insulin dosing, meal data) to provide personalized recommendations for optimizing insulin pump settings strongly suggests the use of sophisticated algorithms, which are characteristic of AI/ML in this context. The previous 510(k) for the same device (K191370) also describes the use of "proprietary algorithms" for this purpose.
No
The device provides recommendations and does not directly apply therapy or directly address the medical condition.
No
The device is described as "decision-support software" that generates recommendations for optimizing insulin pump settings. It analyzes existing data to assist healthcare professionals in management, rather than directly diagnosing a condition.
Yes
The device description explicitly states "DreaMed Advisor Pro is a software device". It gathers and analyzes data from other diabetes devices but does not include any hardware components itself.
Based on the provided information, the DreaMed Advisor Pro is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- DreaMed Advisor Pro's Function: The DreaMed Advisor Pro analyzes data already collected from diabetes devices (CGM, SMBG, insulin pump). It doesn't directly analyze biological specimens. Its purpose is to provide decision support to healthcare professionals based on this collected data.
- Intended Use: The intended use clearly states it's a "decision-support software intended for assisting healthcare professionals in the management of patients with Type 1 diabetes." It focuses on optimizing insulin pump settings based on existing data, not on performing diagnostic tests on biological samples.
Therefore, the DreaMed Advisor Pro falls under the category of a software device that processes and analyzes data from other medical devices, rather than an IVD device that analyzes biological specimens.
No
The provided text does not contain any explicit statement that the FDA has reviewed, approved, or cleared a PCCP for this specific device.
Intended Use / Indications for Use
DreaMed Advisor Pro is a decision-support software intended for assisting healthcare professionals in the management of patients with Type 1 diabetes who:
· use insulin pumps as their insulin delivery therapy;
· monitor their glucose levels using continuous glucose monitoring (CGM) and/or Self-Monitoring Blood Glucose (SMBG) meter;
• are above the age of 6; and
· use rapid acting U-100 insulin analogs in their pump
DreaMed Advisor Pro is indicated for use by healthcare professionals when analyzing CGM, SMBG and pump data to generate recommendations for optimizing a patient's insulin pump settings for basal rate, Carbohydrate Ratio (CR), and Correction Factor (CF); without considering the full clinical status of a particular patient. DreaMed Advisor Pro does not replace clinical judgement.
Product codes
QCC
Device Description
DreaMed Advisor Pro is a software device that is designed to provide insulin therapy adjustment recommendations to physicians to assist in the management of diabetes for patients with Type 1 diabetes using an insulin pump, a continuous glucose monitoring (CGM) system and self-management blood glucose meter (SMBG).
The DreaMed Advisor Pro gathers and analyzes information inputted through qualified Diabetes Management Systems (DMS), which collects biological input information from various diabetes devices. Diabetes device information required and used by DreaMed Advisor Pro includes glucose readings (either CGM sensor readings and/or capillary blood glucose measurements), insulin dosing logs, and meal data during daily routine care.
Following data collection and analysis, the DreaMed Advisor Pro generates results containing summary data and recommendations for adjustments to the patient's insulin therapy parameters, including basal insulin delivery rate(s), insulin to carbohydrate ratio and correction factor (insulin sensitivity). DreaMed Advisor Pro may also advise behavioral changes. Results are sent to a qualified Diabetes Management Systems, which displays results to physicians and a report provided by DreaMed Diabetes. The physician can approve, reject or change the recommendations and issue the updated treatment plan to the patient.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
above the age of 6
Intended User / Care Setting
healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1358 Insulin therapy adjustment device.
(a)
Identification. An insulin therapy adjustment device is a device intended to incorporate biological inputs, including glucose measurement data from a continuous glucose monitor, to recommend insulin therapy adjustments as an aid in optimizing insulin therapy regimens for patients with diabetes mellitus.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include the following:
(i) A complete description of the required data inputs, including timeframe over which data inputs must be collected and number of data points required for accurate recommendations;
(ii) A complete description of the types of device outputs and insulin therapy adjustment recommendations, including how the recommendations are generated;
(iii) Robust data demonstrating the clinical validity of the device outputs and insulin therapy recommendations;
(iv) A robust assessment of all input data specifications, including accuracy requirements for continuous glucose monitors and other devices generating data inputs, to ensure accurate and reliable therapy adjustment recommendations. This assessment must include adequate clinical justification for each specification;
(v) A detailed strategy to ensure secure and reliable means of data transmission to and from the device, including data integrity checks, accuracy checks, reliability checks, and security measures;
(vi) Robust data demonstrating that users can understand and appropriately interpret recommendations generated by the device; and
(vii) An appropriate mitigation strategy to minimize the occurrence of dosing recommendation errors, and to mitigate the risk to patients of any residual dosing recommendation errors to a clinically acceptable level.
(2) The device must not be intended for use in implementing automated insulin dosing.
(3) Your 21 CFR 809.10(b) labeling must include:
(i) The identification of specific insulin formulations that have been demonstrated to be compatible with use of the device;
(ii) A detailed description of the specifications of compatible devices that provide acceptable input data (e.g., continuous glucose monitors, insulin pumps) used to provide accurate and reliable therapy adjustment recommendations;
(iii) A detailed description of all types of required data (inputs) and dosing recommendations (outputs) that are provided by the device; and
(iv) A description of device limitations, and instructions to prevent possible disruption of accurate therapy adjustment recommendations (e.g., time zone changes due to travel).
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August 28, 2020
DreaMed Diabetes Ltd Inbal Beinglass Peled, Director RA/QA 5 Mota Gur St Petah Tikva, 4952701 Israel
Re: K201476
Trade/Device Name: DreaMed Advisor Pro Regulation Number: 21 CFR 862.1358 Regulation Name: Insulin therapy adjustment device Regulatory Class: Class II Product Code: QCC Dated: June 3, 2020 Received: June 3, 2020
Dear Inbal Beinglass Peled:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
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- for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Marianela Perez-Torres, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201476
Device Name DreaMed Advisor Pro
Indications for Use (Describe)
DreaMed Advisor Pro is a decision-support software intended for assisting healthcare professionals in the management of patients with Type 1 diabetes who:
· use insulin pumps as their insulin delivery therapy;
· monitor their glucose levels using continuous glucose monitoring (CGM) and/or Self-Monitoring Blood Glucose (SMBG) meter;
• are above the age of 6; and
· use rapid acting U-100 insulin analogs in their pump
DreaMed Advisor Pro is indicated for use by healthcare professionals when analyzing CGM, SMBG and pump data to generate recommendations for optimizing a patient's insulin pump settings for basal rate, Carbohydrate Ratio (CR), and Correction Factor (CF); without considering the full clinical status of a particular patient. DreaMed Advisor Pro does not replace clinical judgement.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY DreaMed Advisor Pro
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
DreaMed Diabetes Ltd. 5 Mota Gur St. Petah Tikva 4952701 lsrael
Contact Person: Inbal Beinglass Peled Email: inbal.peled@dreamed.ai Phone: +972-52-3642760 Date Prepared: August 28, 2020
Name of Device and Name/Address of Sponsor
DreaMed Advisor Pro DreaMed Diabetes Ltd. 5 Mota Gur Street Petah Tikva 4952701 Israel
Common or Usual Name
Insulin Therapy Adjustment Device
Classification
Class II, 21 CFR 862.1358, Product Code: QCC
Predicate Devices
DreaMed Advisor Pro, K191370
Intended Use / Indications for Use
DreaMed Advisor Pro is a decision-support software intended for assisting healthcare professionals in the management of patients with Type 1 diabetes who:
- . use insulin pumps as their insulin delivery therapy;
- . monitor their glucose levels using continuous glucose monitoring (CGM) and/or Self-Monitoring Blood Glucose (SMBG) meter;
- are above the age of 6; and
- . use rapid acting U-100 insulin analogs in their pump
DreaMed Advisor Pro is indicated for use by healthcare professionals when analyzing CGM, SMBG and pump data to generate recommendations for optimizing a patient's insulin pump settings for basal rate, Carbohydrate Ratio (CR), and Correction Factor (CF); without considering the full clinical status of a particular patient. DreaMed Advisor Pro does not replace clinical judgement.
4
Device Description
DreaMed Advisor Pro is a software device that is designed to provide insulin therapy adjustment recommendations to physicians to assist in the management of diabetes for patients with Type 1 diabetes using an insulin pump, a continuous glucose monitoring (CGM) system and self-management blood glucose meter (SMBG).
The DreaMed Advisor Pro gathers and analyzes information inputted through qualified Diabetes Management Systems (DMS), which collects biological input information from various diabetes devices. Diabetes device information required and used by DreaMed Advisor Pro includes glucose readings (either CGM sensor readings and/or capillary blood glucose measurements), insulin dosing logs, and meal data during daily routine care.
Following data collection and analysis, the DreaMed Advisor Pro generates results containing summary data and recommendations for adjustments to the patient's insulin therapy parameters, including basal insulin delivery rate(s), insulin to carbohydrate ratio and correction factor (insulin sensitivity). DreaMed Advisor Pro may also advise behavioral changes. Results are sent to a qualified Diabetes Management Systems, which displays results to physicians and a report provided by DreaMed Diabetes. The physician can approve, reject or change the recommendations and issue the updated treatment plan to the patient.
Substantial Equivalence
The Advisor Pro is as safe and effective as the previously cleared Advisor Pro. The Advisor Pro has the same technological characteristics and principles of operation as the previously cleared Advisor Pro.
With respect to the indication for use we conclude that the differences in the indication for use between the previous and updated Advisor Pro in allowing patients over the age of 65 to use the device do not affect the safety and effectiveness of the device. This is because based on literature and feedback from clinicians, patients do not receive different insulin therapy management based on their age alone but rather it is based on their overall health and any such considerations are already included in the current labeling. Thus, physicians treating patients over the age of 65 who are otherwise healthy and meet all other indications, device specifications and are not contraindicated could use the device. Anyone else not falling under the indications, falling under the contraindications or not meeting device specifications would not be treated using the device. The indications for use differences between the Advisor Pro and its predicate devices raise no new issues of safety or effectiveness. Thus, the Advisor Pro is substantially equivalent to its predicate device.
Conclusions
DreaMed Diabetes believes that the changes as described in this 510(k) submission, do not present additional safety or effectiveness concerns for the DreaMed Advisor Pro, which is a modification of the legally marketed DreaMed Advisor Pro (K191370).